Kornimate/medical-research-clean huggingface dataset:
european treatment patterns and outcomes associated with first-line cdk4/6 inhibition and hormonal therapies

Conditions: Metastatic Breast Cancer

Summary: a retrospective observational analysis of de-identified data from a multinational medical record review to describe patient characteristics, treatment patterns, and effectiveness of palbociclib + ai as first-line therapy among adult patients with hr+/her2- advanced breast cancer (abc) in europe


Eligibility criteria:
inclusion criteria: * is male or female * has histologically or cytologically confirmed breast cancer diagnosis (hr+/her2- breast cancer) * has received a diagnosis of locally advanced breast cancer not amenable to curative radiation or surgical cure or of metastatic breast cancer (i.e., advanced breast cancer \[abc\]); diagnosis may be de novo (initial diagnosis at abc stage) or recurrent from earlier-stage disease (initial diagnosis of earlier-stage disease with subsequent progression to advanced disease) * has initiated a required first-line therapy of interest: palbociclib plus ai as first-line therapy for abc between september 1, 2016, and july 31, 2020, or ai monotherapy as first-line therapy for abc between january 1, 2010,, and july 31, 2020 * was aged 18 years or older at the time of diagnosis of abc * is living or deceased at the time of record abstraction * has a complete medical record, covering treatment for abc, including any transfer record from other facilities (if applicable) that is available to the abstractor for data abstraction exclusion criteria: * the patient's first treatment after abc diagnosis was chemotherapy (including induction chemotherapy) * the patient has evidence of other active malignant neoplasms within 3 years (except nonmelanoma skin cancer or carcinoma in situ) prior to diagnosis of abc; patients diagnosed with second primary cancer after abc diagnosis will not be excluded * the patient has evidence of prior treatment with any cdk4/6 inhibitor (i.e. palbociclib, abemaciclib, ribociclib) in the early-stage breast cancer setting or treatment with abemaciclib or ribociclib in the abc setting * the patient has participated in a clinical trial related to treatment of abc (including after first-line therapy \[i.e., palbociclib plus ai or ai monotherapy\])

Keywords: breast cancer palbociclib real-world data cdk4/6 effectiveness
treatment of nlp method in women who have experienced postpartum post traumatic stress dissorder

Conditions: Post-Traumatic Stress Disorders

Summary: the purpose of this interventional study is to evaluate the effectiveness of the nlp ptsd protocol in the event of ppptsd. the study's main hypothesis is that the implementation of the nlp protocol will be effective and result in reduction of the overall ptsd level.

post traumatic stress disorder (ptsd) is considered to be a major public health disorder in the western world with 8% prevalence. when including partial/sub-clinic ptsd, prevalence rises dramatically. studies examining the common intervention methods indicate certain clinical effectiveness although none presents sweeping efficiency. therefore, this syndrome is still a significant clinical problem in public health. this study focuses on women population who have experienced trauma in childbirth. such women experience full post traumatic symptoms (full ptsd) or partial/subclinical ptsd. this syndrome is defined in professional literature as ppptsd (post-partum post traumatic stress disorder). while childbirth is a healthy part of the cycle of life, birth itself is an event that may involve a risk to the mother and child life. ppptsd prevalence ranges between 1%-6% and is expressed in at least two of the criteria listed in the dsm. 8.3%-28% of women suffer from partial ppptsd. neuro linguistic programming (nlp) is a "one-on-one" intervention method, connecting neurological processes (n), linguistic (l) and learned behaviors (p), in order to allow conceptual/perceptual, mental and behavioral changes. even though nlp is used since the 1970's and field testimonies report its effectiveness, there are only few studies regarding its effectiveness in the field of ptsd. this study's main objective is to examine the effectiveness of the nlp ptsd protocol. the study population will include approx 30 women, up to 2 years after birth, with ppptsd. the women will be treated in 5 individual sessions implementing the nlp ptsd protocol.

Eligibility criteria:
inclusion criteria: 1. women 2. age: 18-40 3. 2 years from the date of birth; 4. ptsd or ptsd symptoms (indicating partial ptsd) diagnosed as a leading problem in the participant's life 5. hebrew speaking 6. insured by maccabi health services exclusion criteria: 1. presence of one of the following: (a) mental retardation; (b) schizophrenia or other mental illnesses; 2. changes in medication dose during the study or during the three prior months; 3. suicide attempts or self-harm; 4. alcohol or drug use; 5. postpartum depression; 6. incompetent 7. stillbirth
thromboelastography guides a multicentre cluster controlled study of plasma exchange for hepatitis b associated acute-on-chronic liver failure

Conditions: 28 Day Mortality

Summary: in the past ten years, the extracorporeal liver support system has been widely used in clinical practice as a first-line treatment of liver failure. plasma exchange (pe) can remove toxic substances in aclf patients, reduce liver damage, and replenish coagulation factors, albumin and immunoglobulins, thereby improving the liver's microenvironment and accelerating liver regeneration and functional recovery. the aclf study showed that pe can improve the symptoms of patients and improve the short-term prognosis of patients, but there are still studies showing that pe does not significantly improve the short-term prognosis of patients. therefore, the therapeutic effect of pe on aclf is still controversial. we consider that some people may benefit from plasma exchange, and new indicators are needed to guide disease stratification treatment. our multi-center prospective data show that plasma exchange has a tendency to improve survival in aclf-2. after stratifying with adp inhibition rate in aclf-2, patients with adp inhibition rate greater than 30% will be treated 28 days after pe treatment. the prognosis is improving. therefore, we consider that pe is expected to reduce the mortality of patients with aclf 2 with an adp suppression rate greater than 30%, but prospective large-sample clinical studies are still needed.


Eligibility criteria:
inclusion criteria: * 1) 18-80 years old; 2) chronic hbv infection related: hbsag positive for more than 6 months; 3) easl-aclf grade 2 exclusion criteria: * 1) other causes of chronic liver disease; 2) active bleeding and diffuse intravascular coagulation; 3) those who have been severely allergic to blood products and heparin in the past; 4) circulatory failure; 5) respiratory failure; 6) patients with unstable period of cardiovascular and cerebrovascular infarction; 7) those who have received platelet transfusion or artificial liver within 1 week; 8) patients with liver cancer or other malignant tumors; 9) pregnant and lactating women; 10) those with other serious chronic diseases; 11) fail to sign the informed consent form; 12) circumstances that the researcher considers inappropriate to participate in the research.
study on female patients' mammographic texture features

Conditions: Breast Cancer; Artificial Intelligence; Mammography

Summary: mammography is the most common method for breast imaging, and it provides information for model building and analysis. radiomics applied to mammography has the potential to revolutionize clinical decision-making by providing valuable insights into risk assessment and disease detection. despite this, the influence of imaging parameters and clinical and biological factors on radiological texture features remains poorly understood. there is a pressing need to overcome the obstacle of system-inherent effects on mammographic images to facilitate the translation of radiological texture features into routine clinical practice by enabling reliable and robust ai-based or ai-aided decision-making. furthermore, understanding the relationship between imaging parameters, textural features, and clinical and biological information supports the clinical use of ai. the objective of this study is to evaluate ai methods for clinical practice and to study how it relates to clinical factors and biological features.


Eligibility criteria:
inclusion criteria: * candidate is a biological female aged 18 years or above; * candidate is willing and able to give informed consent and gives their written consent for the participation in the study; * there is a clinical indication for a uni- or bilateral mastectomy exclusion criteria: * candidate lacks the capacity to provide informed consent; * candidate has breast implants
study of lenalidomide in combination with sunitinib to evaluate the safety and efficacy in patients with renal cell carcinoma

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study was to determine the maximum tolerated dose, safety, and effectiveness of lenalidomide (cc-5013) administered in combination with sunitinib as treatment for patients with renal cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. metastatic renal cell carcinoma. 2. eastern cooperative oncology group (ecog) performance status of ≤ 1. exclusion criteria: 1. prior chemotherapy. 2. prior treatment with lenalidomide, thalidomide, pomalidomide, or sunitinib. 3. laboratory values outside normal ranges. 4. myocardial infarction (mi) within past 12 months. 5. current congestive heart failure.
digital sleep program for college students with insomnia

Conditions: Insomnia

Summary: this randomized controlled trial (rct) study aims to evaluate the effectiveness of a digital-based multimodal sleep management program compared to a waitlist control group in improving sleep-related outcomes, including insomnia severity, daytime sleepiness, objective sleep parameters, and sleep reactivity to stress, as well as psychological health indices, such as depression, anxiety, and resilience. additionally, this study seeks to examine the mediating role of different chronotypes in the effectiveness of the sleep intervention on the outcomes of interest.

this is a parallel-group, randomized controlled trial (rct). 90 participants who experiencing insomnia for at least 3 months with college students will be enrolled. eligible participants who complete the baseline measurements will be randomly allocated to a digital-based multimodal sleep management program group (n = 45) and a waitlist control group (n = 45). the primary outcome is insomnia severity, assessed using the insomnia severity index (isi). the secondary outcomes include daytime sleepiness, objective sleep parameters, sleep reactivity, resilience, anxiety, and depression, which will be examined using the epworth sleepiness scale (ess), a wearable sleep tracker, the ford insomnia response to stress test (first), the brief resilience scale (brs), the state-trait anxiety inventory (stai), and the beck depression index ii (bdi-ii), respectively. additionally, chronotype will be assessed using the morningness-eveningness questionnaire (meq) as a moderating role to be tested in this study. all outcomes will be measured at three time points: t0 (baseline assessment), t1 (immediately after the 4-week intervention period), and t2 (4 weeks after the intervention period).

Eligibility criteria:
inclusion criteria: 1. registered as a full-time student 2. aged 18 to 26 years old 3. experiencing insomnia for at least three months 4. currently own and use a personal mobile device 5. ability to read and speak chinese 6. not taking hypnotics, sedatives, or antidepressants 7. not pregnant or lactating exclusion criteria: 1. using a smartphone model that cannot support the app 2. currently using other sleep program apps 3. meeting a stop-bang score of ≥3

Keywords: anxiety chronotypes daytime sleepiness depression digital-based sleep management insomnia resilience sleep reactivity mindfulness-based breathing
anesthesia preferences in the covid-19 pandemic: general anesthesia or regional anesthesia?

Conditions: COVID-19

Summary: as the covid-19 pandemic continues, humanity has started to adapt to it. in our study, we aimed to examine the adaptation of anesthetists to the pandemic and its behavioral reflection on their work.

all surgeries and anesthesia methods performed in the university hospital were examined. the cases and anesthesia practices of the departments were examined. years with and without pandemics were compared.

Eligibility criteria:
inclusion criteria: * all operations exclusion criteria: * those who refuse to have surgery * non-operational

Keywords: covid-19 regional anesthesia general anesthesia
study of the safety of use of intravitreal sok583a1 provided in a prefilled syringe

Conditions: Neovascular Age-related Macular Degeneration (nAMD)

Summary: this was an open-label, single arm, multicenter, phase iiib study in subjects with (wet) namd, eligible for ivt aflibercept treatment.

this was an open-label, single arm, multicenter, phase iiib study in subjects with namd, eligible for intravitreal (ivt) aflibercept treatment. screening and baseline could be performed on the same day. subjects with namd received a single dose of study treatment (2 mg sok583 in 0.05 ml) in line with the eylea us pi, which recommends a dose of 2 mg aflibercept (0.05 ml) administered by ivt injection. only subjects already under ivt eylea treatment and hence familiar with the ivt procedure were eligible for the study. administration of the study treatment was embedded into their individual dosing schedule. demonstration of the safe use of the pfs containing sok583a1 was based on the performance of at least 3 different ophthalmologist teams. follow-up visits were performed on-site on day 8 (±2 days) and on day 31 (+4 days - end of study visit). subjects participated for 30 to 34 days in the study including baseline and treatment on day 1 (screening and baseline could be performed on the same day) and the last safety follow-up on day 31 (a time window of plus 4 days was allowed for the last safety follow-up).

Eligibility criteria:
inclusion criteria: * subjects ≥ 50 years of age at baseline * subjects diagnosed with namd (uni- or bilateral) * subjects already under ivt eylea treatment (last injection of the induction period or maintenance phase) exclusion criteria: * active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study eye at baseline, which is of clinical significance according to the investigator's judgment, such as active infections of the anterior segment; this includes conjunctivitis (except mild blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis * any uncontrolled ocular hypertension or glaucoma in the study eye (defined as intraocular pressure (iop) ≥ 26 mmhg, despite treatment with anti-glaucomatous medication) * history of a medical, ocular or non-ocular condition, that in the judgment of the investigator, would preclude a safe administration of investigational product * visual acuity score (vas) worse than 20/200 on a snellen chart, the generally accepted level of legal blindness * receipt of any systemic anti-vegf within the last 6 months prior to enrollment * uncontrolled hypertension (defined as a systolic value ≥ 160 mmhg or diastolic value ≥ 100 mmhg at screening) * subjects who do not comply with the local covid-19 regulations of the study site

Keywords: open label study, intravitreal injection, biosimilar, aflibercept, pfs
comparison of glucovance to insulin for diabetes during pregnancy

Conditions: Gestational Diabetes; Type 2 Diabetes; Pregnancy

Summary: pregnant women with gestational or type 2 diabetes who require medication are placed in one of two groups: insulin injections or glucovance (oral administration). blood glucose is checked 5 times per day, and medication adjusted by perinatologist according to glucose levels. the hypothesis is that patients will have similar or improved blood glucose control on an oral agent as compared to control on insulin.

according to acog guidelines, patients between 24 and 28 weeks gestation will be screened with a 1 hour glucose tolerance test (gtt) by their obstetrician. those with elevated glucose levels will undergo a 3 hour gtt. according to routine ob standards, if the blood glucose is elevated on 2 or more of 4 parameters during this test (\> 95 fasting, \> 180 at 1 hour, \> 155 at 2 hours, \>140 at 3 hours), the patient will begin receiving dietary therapy using ada guidelines. if blood glucose levels remain 20% above a fasting of 90 \& post parandial of 120 with diet alone during a period of 1-3 weeks after diagnosis, the patient will be invited to participate in this study. type 2 diabetics who have been diagnosed prior to pregnancy will also be included. these patients may enroll in the study prior to 24 weeks gestation, entering at the time of referral. patients who give consent for participation will be randomly assigned to either insulin therapy (the usual standard of care), or to oral glucovance therapy (the experimental group). glucovance will be started at 1.25mg/250mg bid. nph \& regular insulin will be started on a 1unit/kg basis bid. both groups will receive care according to the current standard for gestational diabetics and pregnant type 2 diabetics. the perinatologist and diabetes educator will evaluate the blood glucose record and assess the patient's adherence to the ada diet weekly and will determine when the insulin or glucovance needs to be increased. if the patients in the glucovance group continue to be poorly controlled with 4 tablets/day (5mg/500mg), the therapy will be continued and insulin will be added to the management. statistical analysis will compare the two groups for myriad factors including vaginal versus operative deliveries, hemoglobin a1c, fructosamine, and glucose at delivery, infant birth weight, infant complications, initial infant blood glucose.

Eligibility criteria:
inclusion criteria:gestational diabetes by acog definition or type 2 diabetes in pregnancy hyperglycemia despite following ada diet english or spanish speaking - exclusion criteria:already requiring insulin serum creatinine \> 1.3 or creatinine clearance \< 75ml/minute liver disease -

Keywords: diabetes pregnancy
evaluation of l-prf as an antibiotic slow-release biological device in the treatment of moderate periodontitis

Conditions: Periodontitis

Summary: this study aimed to evaluate the efficacy of leukocyte platelet-rich fibrin (l-prf) as a local sustained released device for antibiotics.


Eligibility criteria:
inclusion criteria: * patients suffering from stage ii periodontitis with probing depth and exhibiting bleeding on probing. * patients showing good oral hygiene. * no history of periodontal therapy (surgical and non-surgical) for the past 6 months. exclusion criteria: * patients with known systemic and debilitating diseases. * patients who had any previous adverse reactions to the products (or similar products) used in this study. * patients who have any autoimmune diseases. * patients who have any known disease that interfere with periodontal procedure. * smokers. * pregnancy and lactating women. * use of antibiotics during the last 6 months.
exercise as an adjunctive treatment for cocaine dependent patients

Conditions: Cocaine Dependence

Summary: the purpose of this study is to evaluate if exercise added to usual treatment improves cocaine dependence treatment. the primary objective of this study is to investigate if exercise can facilitate cocaine craving reduction. the secondary aims are to evaluate if exercise can reduce negative mood states, improve quality of life and facilitate abstinence of cocaine.

this study is designed as two-groups, randomized controlled trial to evaluate the effectiveness of an 8-week exercise program added to usual treatment compared with a health education program in 20 cocaine dependent patients. these participants will be randomized to one of the following two groups: a) exercise group: supervised moderate-vigorous exercise in group based on strength and calisthenics exercises, b) control group: supervised health education in group. all participants must have dsm-iv diagnosis of cocaine dependence as the primary disorder and must be in treatment.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of cocaine dependence as primary disorder * age between 18 and 60 years * current psychosocial cocaine treatment exclusion criteria: * medical problems that contraindicate the participation in an exercise program * family history of sudden death and/or early death due to cardiovascular reasons * current inclusion in a regular exercise program

Keywords: exercise cocaine dependence
vit d3 and omega 3 in chemo induced neuropathy

Conditions: Cancer; Neuropathy

Summary: the purpose of this study is to determine whether administration of mammalian omega 3 fa(fatty acid) with vitamin d3 supplements would lower or prevent the risk of neuropathy due to chemotherapy.

the primary objective of this study is to evaluate the impact of mammalian oil omega 3 fa with vitamin d3 supplementation on resolution or prevention of taxanes or platinum induced peripheral neuropathy compared with placebo. patients will be allocated to receive the omega 3 fa \& vitamin d3 supplements or placebo for 6 months. approximately 600 patients in total will be enrolled in the 2 study arms. the evaluation of neuropathy will be accomplished by electromyography (emg), total neuropathy score(tns), brief pain inventory (bfi) and the 11-item fact/gog-ntx, version 4 questionnaire (a subscale validated to assess neuropathy due to chemotherapy). in addition, other validated functional measures such as "time to button a six hole shirt" and "50 ft walk speed test" will be used to test patients physical limitations imposed by peripheral neuropathy. all our patients will undergo an emg at their first visit, in 3 months and after 6months. previously mentioned functional measures will also be completed at the patients' first visit, in 3 months and after 6 months.

Eligibility criteria:
inclusion criteria: * will be receiving chemotherapy(platinums and/or taxanes) in the following 2 weeks. * histologically confirmed diagnosis of cancer * ecog 0 to 2 exclusion criteria: * prior chemotherapy treatment * pre-existing peripheral pn due to dm,hiv, alcohol abuse, thyroid dysfunction and hereditary pn associated disorders. * taking any nutritional supplement( fish oil, vitamins and minerals) at least there months before enrollment.

Keywords: chemotherapy omega 3